The reported event was unconfirmed since the reported failure could not be reproduced.The visual evaluation of the returned sample noted one opened (without original packaging) silicone foley catheter with manufacturing lot number ngcn1503.It was noted that there was no flash on the catheter.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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